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Breast Core-Needle Biopsy: Clinical Trial of Relaxation Technique versus Medication versus No Intervention for Anxiety Reduction¹

¹ From the Iris Cantor Center for Breast Imaging, Department of Radiology (M.E.B., D.K.W., I.M.A., D.L.K., J.W.S., L.W.B.), Department of Psychiatry, Neuropsychiatric Institute (M.E.B.), and UCLA-Jonsson Comprehensive Cancer Center (L.W.B.), David Geffen School of Medicine at UCLA, 200 UCLA Medical Plaza, Room 165–47, Box 956952, Los Angeles, CA 90095-6952; Department of Medical Imaging, St Luke’s Regional Medical Center, Boise, Idaho (J.R.M.); and Valencia Imaging, Henry Mayo Memorial Hospital, Valencia, Calif (D.L.K.). From the 2000 RSNA Scientific Assembly. Received February 12, 2003; revision requested April 29; revision received April 2, 2004; accepted April 22. Address correspondence to L.W.B.

	ABSTRACT

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PURPOSE: To evaluate effectiveness of oral anxiolytic medication versus relaxation technique for anxiety reduction in women undergoing breast core-needle biopsy (CNB).

MATERIALS AND METHODS: The institutional review board reviewed and approved the study. Informed consent was obtained from 143 consecutive women scheduled for breast CNB. Women were randomized as follows: no anxiety intervention (usual care group), relaxation therapy with an audiotape of classical music and ocean sounds during CNB (relaxation group), and 0.5-mg of alprazolam administered orally 15 minutes before CNB (medication group). Anxiety before, during, and 24 hours after the procedure was assessed with State-Trait Anxiety Inventory and self-reported visual analog scale from 0 (no anxiety) to 10 (worst anxiety). Data analysis was performed with statistical software. Descriptive statistics were computed for all variables. Group differences were determined with analysis of variance. Differences in mean values were assessed with Bonferroni multiple comparison procedure. Categorical demographic differences were assessed with ² statistic.

RESULTS: Preprocedural State-Trait Anxiety Inventory scores indicated that women were not inherently anxious: usual care group, score of 44.63; relaxation group, 45.74; and medication group, 49.1. Scores represented significantly elevated anxiety for women in all three groups when compared with the normative value of 35.12 (P < .0001), with no statistically significant differences between the scores of the three groups. Women in medication group reported significant reductions in anxiety (–44%) from levels determined before the procedure to levels determined during the procedure (P = .02) and significant reduction during the procedure when compared with changes in usual care (+15%) and relaxation (–8%) groups (P = .02). Women in all three groups reported significant reduction in anxiety from levels determined before the procedure to levels determined at 24 hours after it (P < .0001). There was no significant difference (P = .95) in 24-hour postprocedural anxiety levels among the three groups.

CONCLUSION: Use of oral anxiolytic medication before breast CNB can significantly reduce anxiety women experience during the procedure.

© RSNA, 2004

	INTRODUCTION

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Breast core-needle biopsy (CNB) has become an accepted procedure for the evaluation of mammographically detected lesions (1). Breast CNB offers decreased morbidity and scarring when compared with surgical breast biopsy. It has been reported, however, that patients experience clinically marked levels of anxiety while they undergo breast biopsy, whether it is an open biopsy or CNB (2–7). In fact, the anxiety levels for a breast biopsy have been reported to exceed the anxiety levels for patients who undergo elective surgery, such as cholecystectomy (2). This is understandable, as many women fear the worst outcome when they undergo a breast biopsy (8). These feared outcomes include the possibility of disfiguring surgery, radiation treatment, and chemotherapy, as well as the possibility that the disease may be incurable (9). In addition, coping strategies available to these women outside of the procedure room, such as information gathering, denial, distraction, and social support, are not available during the biopsy procedure (10).

Clinically significant levels of anxiety have been reported in a sample of women who were anticipating, undergoing, and remembering breast CNB (7). In our literature search, we identified no previous studies of topics related to anxiety reduction specifically for breast CNB. van Vlymen et al (11), however, demonstrated that women who received intravenous benzodiazepine prior to wire-localization procedures performed in the radiology suite reported a 55% reduction in anxiety. Patients who received the intravenous medication also reported a 55% decrease in pain or discomfort compared with that which was reported for those patients in a placebo-controlled group. The use of intravenous sedation during interventional radiologic procedures, however, requires monitoring for respiratory depression, and an anesthesiologist has to be present to administer the sedative (12). This typically adds substantial expense and is not a feasible option for breast CNB.

We undertook this study to evaluate the effectiveness of an oral anxiolytic medication versus a form of relaxation technique (an audiotape of music and ocean sounds) for reduction of anxiety in women who undergo breast CNB.

	MATERIALS AND METHODS

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Subjects
We evaluated 143 consecutive women scheduled for breast CNB of nonpalpable mammographically detected breast abnormalities. Subjects were recruited at three hospital study sites. These sites included UCLA Medical Center, Los Angeles, Calif (n = 84, 58.7%); St Luke’s Medical Center, Boise, Idaho (n = 27, 18.9%); and Henry Mayo Newhall Medical Center, Newhall, Calif (n = 32, 22.4%).

Inclusion criteria for participation included the following: Subjects had to be willing to be randomized to any of three treatment arms, had to speak English, and had to be accompanied by a person who was able to drive them home. Exclusion from the study resulted when patients took anxiety reduction medications prior to arriving for their appointment for CNB.

Study Design
The study was reviewed and approved by our institutional review board. Subjects were contacted by means of telephone by the same clinical psychologist (M.E.B.) prior to their appointment for breast CNB. During the call, each potential subject was informed of the details and intent of the study and then invited to participate. Subjects who indicated interest were scheduled to meet with the psychologist on the day of the breast CNB to provide informed consent and undergo baseline testing.

The participating patients were randomly assigned to one of three study arms: a usual care group (no intervention for anxiety reduction), a relaxation group (audiotape with classical music and ocean sounds, used before and during the breast CNB, with all patients listening to the same audiotape), and an anxiety-reducing medication group. Alprazolam tablets (Xanax; Pharmacia & Upjohn, Peapack, NJ), 0.5 mg for patients 18–65 years old and 0.25 mg for those 66–80 years old, were administered orally 15 minutes prior to CNB. Consent for biopsy was obtained prior to administration of alprazolam.

Patients were asked by one investigator (M.E.B.) about previous experience with self-relaxation techniques. The previous experience with self-relaxation techniques (either self-taught or professionally taught) was assessed with comparison of the three randomized study groups. In the usual care group, 31.2% (15 of 48) of patients had previous experience with self-relaxation techniques; in the relaxation group, 34.0% (16 of 47) had previous experience with these techniques; and in the medication group, 33.3% (16 of 48) had previous experience with them. No significant difference (P = .95) in previous experience with self-relaxation techniques was found among the three groups by using a ² test for homogeneity. Demographics for patients in regard to age, marital status, ethnicity, and education reflected no significant differences among the three randomized groups, as shown in Table 1, which also includes the number of women in each group. Patients were also asked to complete a history sheet for reporting any previous breast biopsy or any history of previous cancer (not necessarily breast cancer).

Anxiety Assessment Instruments
Two psychometric scales were used in this study. Anxiety levels were assessed with the State-Trait Anxiety Inventory before the procedure and at 24 hours after the procedure (13). The State-Trait Anxiety Inventory is a 40-item self-reported questionnaire that is used to assess state and trait anxiety. Trait anxiety refers to "relative stable individual differences in anxiety proneness" and reflects core differences among people in regard to the tendency to respond to situations that are perceived as threatening. Trait anxiety is not expected to fluctuate over time. In contrast, state anxiety is conceptualized as "a transitory emotional state or condition that is characterized by subjective, consciously perceived feelings of tension and apprehension, and heightened autonomic nervous system activity" (13). Responses to each of the 40 questions are answered with a scoring scale from 1 (not at all) to 4 (very much so). An example of a trait anxiety statement is "I worry too much over something that really doesn’t matter." An example of a state anxiety statement is "I am tense." The test is divided into 20 trait anxiety statements (how a patient feels generally) and 20 state anxiety statements (how a patient feels at this moment), and the patient responds with a score. Scores for state anxiety and those for trait anxiety each can range from 20 to 80.

The test has been validated in several populations, which include college students, clients with emotional problems, hospitalized neuropsychiatric patients, and general medical and surgical patients. Trait norms for female undergraduate college freshmen and general medical and surgical patients have been published in the State-Trait Anxiety Inventory Manual (13). Test-retest reliability coefficients reported for the trait scale ranged from r = 0.76 to r = 0.86. State scale reliability coefficients reported ranged from r = 0.16 to r = 0.54 (lower correlations would be expected because of the fluctuating nature of state anxiety). Validity coefficients reported ranged from r = 0.52 to r = 0.82 when the State-Trait Anxiety Inventory was correlated with three other well-standardized measures of anxiety (13). Preprocedural anxiety was assessed with on-site questionnaires. The same psychologist (M.E.B.) collected the 24-hour postprocedural data by means of telephone interviews.

A second self-reported test was used to measure anxiety before, during, and after the procedure. Responses to this test were indicated with a visual analog scoring scale from 0 to 10, which is a graphic rating scale with a 10-cm baseline divided into 10 equal parts from 0 (no anxiety) to 10 (worst possible anxiety), with a score of 5 (moderate anxiety) as the midpoint. This assessment tool was modeled from a reference guide for clinicians about treatment of pain in adults with cancer (14). Scales of this type have been shown to have high correlation with other psychological assessment instruments that are used to measure the same variable (eg, mood, pain), thus establishing criterion validity (15). Acceptable reliability estimates also have been established among rating scales of this type across time (16). The preprocedural self-reported questionnaire was completed by the patient at the breast imaging center before the procedure began. The self-reported tests for anxiety determined during and after the procedure were administered by means of telephone interviews on the following day. Only three of the patients had received the biopsy results at 24 hours after the procedure.

Statistical Analysis
Data analysis was performed with statistical software (BMDP, Statistical Solutions, Saugus, Mass; SPSS, version 10.0, SPSS, Chicago, Ill). Descriptive statistics were computed for all variables. Group differences were determined by using analysis-of-variance methods. The Bonferroni multiple comparison procedure was used to assess contrast differences. Categorical demographic differences were assessed by using the ² statistic. Statistical significance was defined as P .05. Varying sample sizes resulted when patients did not respond to all items concerning their medical history in self-reported questionnaires.

	RESULTS

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State-Trait Anxiety Inventory Data
Table 2 presents the preprocedural and 24-hour postprocedural state anxiety mean scores for the patients in the three study groups. No significant differences were found among the study groups in regard to these variables. The preprocedural state anxiety mean score for the three randomized study groups combined was 46.50 (SD = 13.0, n = 143), compared with the normative value for female nonpsychiatric patients of 35.12 (SD = 9.3) (12). All three groups had preprocedural state anxiety levels that were significantly higher than the normative value (P < .0001). In addition, patients in each of the three study groups reported significant reductions in anxiety from the level determined before the procedure to that obtained at 24 hours after the procedure (P < .0001). This decline in reported anxiety occurred despite the fact that only three patients had been notified of their biopsy results during the 24-hour postprocedural period.

Visual Analog Scale Data
Patients’ self-reported responses in regard to anxiety before, during, and after the procedure that were indicated by using the visual analog scoring scale are presented in Table 3. There was no significant difference in anxiety among the three study groups before the procedure. Patients in the medication group, however, reported significantly less anxiety during the procedure, as compared with the other two study groups (P = .02). In addition, only patients in the medication group experienced a significant decrease in anxiety between levels determined before the procedure and those determined during the procedure (P = .02). Among the three study groups, there was no significant difference in anxiety levels at 24 hours after the procedure.

Table 4 shows the effect of a history of breast biopsy on the percentage of change in anxiety between levels determined before the procedure and those determined during the procedure. The greatest decrease in anxiety (–45%) occurred in the patients in the medication group who had no history of breast biopsy. Significant reductions in anxiety between levels determined before the procedure and those determined during the procedure (P = .05) were found when we compared patients in the medication group who did not have a history of a breast biopsy with those in the usual care group who did or did not have a history of breast biopsy.

	DISCUSSION

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Our study documents the high levels of anxiety associated with a breast CNB and demonstrates the effectiveness of an oral anxiolytic medication in the reduction of that anxiety during the biopsy procedure. Key findings included documentation of the high levels of anxiety experienced by women who were undergoing CNB; evidence of effectiveness of an oral anxiolytic medication in the reduction of the anxiety associated with breast CNB; and the lack of statistically significant effectiveness of a simple relaxation intervention.

Patients in each of the three randomized groups reported markedly elevated levels of anxiety prior to breast CNB. The preprocedural mean state anxiety score for all groups combined was 46.50 (SD = 13.0, n = 143), compared with the normative trait anxiety score of 35.12 (SD = 9.3) for female nonpsychiatric patients (13). The preprocedural anxiety levels in these patients was close to the mean preprocedural state anxiety score of 47.11 (SD = 13.5; n = 52) reported previously for another group of patients who underwent breast CNB (7).

We also analyzed a number of variables that might have influenced the anxiety of the 143 study patients during CNB. For example, the anxiety experienced was not related to the site where the biopsy was performed: there was no statistically significant difference in anxiety levels during the procedure among the three sites (P = .44). Furthermore, there was no statistically significant difference in anxiety levels during the procedure for stereotactically guided (n = 116, 81.1%) versus US-guided (n = 27, 18.9%) procedures (P = .93).

Could the anxiety levels be explained by the experience of the radiologist performing the procedure? Results of our statistical analysis of the data showed that there was no statistically significant difference in anxiety levels during the procedure (P = .28) for women who underwent procedures performed by breast imaging fellows in training (n = 66, 46.2%) versus those who underwent procedures performed by faculty members or private practice staff radiologists (n = 77, 53.8%).

Was the level of anxiety during the procedure related to the likely outcome, based on the radiologist’s level of suspicion, which could have been conveyed to the patient? This is not the likely explanation of the level of anxiety, since there was no statistically significant difference (P = .74) in anxiety levels during the procedure between women whose CNB results turned out to be benign (n = 106, 74.1%) and those who received a diagnosis of cancer (n = 37, 25.9%).

As a result of the analyses of these multiple variants, we concluded that the level of anxiety that these patients experienced during the procedure was related to the group to which they were randomly assigned rather than to these other variables.

At 24 hours after the procedure, anxiety levels had returned to normal for patients in each of the three randomized groups. The decrease in anxiety to normative levels occurred despite the fact that only three of the 143 patients in the study had received their biopsy results at 24 hours after the procedure. Therefore, the preprocedural anxiety reported by the patients cannot be attributed solely to concerns about their biopsy results. Rather, these findings may also reflect the inherent stress associated with undergoing the biopsy itself.

The most important finding of this study was that oral anxiolytic medication was effective in the significant reduction of the anxiety women experienced during breast CNB. The administration of the anxiolytic medication did not require introduction of an intravenous catheter or the presence of nursing or anesthesia personnel during the procedure (17).

The patients in the relaxation group demonstrated a trend toward a decrease in anxiety during the procedure when compared with patients in the usual care group, who reported increased anxiety during the procedure. In terms of the relaxation technique, our study focused on the general population of patients encountered in our practices. More comprehensive relaxation techniques and patient training prior to the procedure could potentially have yielded greater effectiveness for patients in the relaxation group. We used only music and ocean sounds with a headset as our intervention. More in-depth training is sometimes performed with relaxation interventions and has been shown to significantly decrease symptoms such as nausea, anxiety, and pain (17–20). However, this type of training may be impractical for patients who are undergoing a breast CNB and who generally want to have the procedure performed as soon as possible.

We evaluated methods to reduce anxiety during breast CNB. The relatively short follow-up of our study precluded the evaluation of other potential psychological sequelae, such as the effect of biopsy results on anxiety. The investigators are also aware that some preprocedural anxiety is related to anticipation of potentially malignant results. This effect, however, should be evenly distributed across the three study groups and was not the focus of the current study.

When we analyzed between-group differences in patients with a history of either a previous biopsy or cancer, some differences may not have been detected because of the small sample sizes in those groups.

	FOOTNOTES

 
Abbreviations: CNB = core-needle biopsy, SD = standard deviation

Authors stated no financial relationship to disclose.

Author contributions: Guarantor of integrity of entire study, L.W.B.; study concepts, L.W.B., M.E.B., D.K.W., J.R.M., D.L.K.; study design, L.W.B., M.E.B., D.K.W., J.W.S.; literature research, L.W.B., M.E.B.; clinical studies, L.W.B., M.E.B., J.R.M., D.L.K.; data acquisition, M.E.B., I.M.A.; data analysis/interpretation, J.W.S., M.E.B., D.K.W., L.W.B., I.M.A.; statistical analysis, J.W.S.; manuscript preparation, editing, and final version approval, L.W.B., M.E.B., J.W.S., D.K.W.; manuscript definition of intellectual content, all authors; manuscript revision/review, L.W.B., M.E.B., J.W.S., D.K.W., I.M.A.

	REFERENCES

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